Fwd: [karmayog] Are generic drugs safe?
---------- Forwarded message ----------
From: Pearl - Karmayog <info@...>
Date: Tuesday, April 29, 2014
Source: Mumbai Mirror
Are generic drugs safe?
Generic market is cheaper because they do not have to pay for clinical trials, advertising and promotion
Docs say that though they prefer branded drugs, they would let their patients decide what they want.
The pharmaceutical industry spends an enormous sum of money on the research and development of new drugs every year. Sometimes it is even more than $350 million per drug that comes to market. Some estimate that as much as 95 percent of the new medicines tested do not see the light of the day because of ineffectiveness and safety concerns. With such large sum of money at stake, altruism has been thrown o the wind.
Alexander Fleming discovered penicillin without patenting it and the drug has gone on to save billions of lives around the world. Salk manufactured the polio vaccine and did not patent it. When an interviewer asked him why he did not patent it, he retorted: can you patent the sun? However, pharmaceutical companies are given patenting rights on the products so that they could earn profits and recover the money spent on research and development of a particular drug. And when the patent expires, the drug can be sold in the market in its non-branded or generic form. India exports generic drugs worth $11billion per year.
Today, eight out of 10 prescriptions in the USA have the names of the generic drugs written on them and this is expected to grow over the years since a number of drugs have come of their patents. The food and drugs administration of USA has strict norms regarding generic medicines: they must have the same qualities and functionalities as their branded equivalents. Moreover, all manufacturing, packaging and testing sites of generic drugs must pass the standards that are used for the branded products. The Maharashtra government is now insisting that doctors here do the same in order to promote generic drugs as they are cheaper.
A Journal of American Medical Association study shows us that out of 38 drugs trials where branded cardiac medicines were compared with similar generic drugs, nothing suggests that the branded product was better than the generic one. A study done by the food and drug administration of USA shows that the difference in consumption of generic drugs to its branded counterpart is approximately 3.5 percent and that generic medicines have saved over $158 billion in 2010. Generic market is cheaper because they do not have to pay for clinical trials, advertising, promotion and marketing of the drug. It is therefore evident that cheap drugs do not mean they are of inferior quality.
But strangely, National Health Service of the United Kingdom suggests that patients who consume epilepsy medicines should not jump from branded to generic drugs as it may cause health hazards. Similar suggestion is made for patients consuming drugs to treat ulcer of the large intestine, insulins for diabetes, theiphylline to treat asthma, nifedipine to keep blood pressure in check and diltezium for heart diseases.
Pleere Blier, in an article written a decade ago in the Journal of Psychiatry and Neuroscience, wrote anecdotal episodes that elucidated problems of generic drugs. He wrote about a patient who was on blood pressure medication and suddenly fainted after switching from branded to generic. When this man switched back to his original branded medicine his pressure became normal. It has also been observed that patients, who responded well to Fluoxentine, a prozac patented antidepressant, stopped responding to its generic counterpart.
Such anecdotes make physicians wary of generic drugs. Because, healthy response to a drug is way more important for a patient than saving money. And that is why physicians generally prescribe drugs that have been tested and they have faith on.
Moreover, we should also think about the excipients that generic drugs have in them and whether they are good for our health. Excipients are inert substances that are added to the active ingredients to help maintain the shelf life of a drug. Though inert, they affect the blood levels of drugs depending on their chemical quality.
So after the state government asked doctors to prescribe generic drugs alongside branded ones, I asked my colleagues what they are planning to do. Most of them said that they will leave it for the patients to decide though they would stress on using branded drugs and do the same while treating their family members.
- Doctors prescribing a branded drug and then telling the patient that he has a choice to use a generic version will confuse the patient. Doctors have to prescribe the generic versions and advise the patients to report any abnormal reaction (which will be very rare).Yes, there is a possibility of a generic version not acting the same way as the branded version in rare cases. This may happen because the main ingredient (a chemical substance that fights the ailment) used by the generic drug manufacturer may have been made by a different process and may contain minute quantities of impurities that are not present in the branded version. The change of action may be also because of the exipients used.It may however be noted that even in branded product minute variations are possible from batch to batch.Drug control authorities permit generic versions only after adequate test results are submitted on the efficacy of the product. The products are tested during manufacture and at the end of manufacture.Generic drugs are safe and they are less expensive. If somebody is shifting to a generic version from a branded version particularly in case of serious ailments, there is need for caution.